Real-World Data on Health-Related Quality of Life Assessment in Patients With Breast Cancer Receiving Subcutaneous Trastuzumab

Abstract

Purpose:Trastuzumab, a humanized anti-human epidermal growth factor receptor 2 (anti-HER2) antibody delivered intravenously, has revolutionized the treatment of patients with breast cancer overexpressing HER2 protein. Recently, a newer subcutaneous formulation was shown to have comparable efficacy to the initial intravenous trastuzumab. In this study, we aimed to evaluate the impact of subcutaneous trastuzumab on the health-related quality of life (HRQoL) of patients diagnosed with early or metastatic HER2-overexpressing breast cancer.Methods:Patients were provided with the EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and the BR-23 questionnaires. The scoring of questionnaires and patient’s sociodemographic and clinicopathologic characteristics were recorded and analyzed by descriptive and correlation statistics employing t test and 2-way analysis of variance.Results:A total of 163 patients agreed to participate in the study. About 90 of 163 patients (55.21%) received subcutaneous trastuzumab and 21 patients intravenous trastuzumab (12.88%). A control group of 52 HER2+ patients received chemotherapy without trastuzumab (31.90%). Patients receiving subcutaneous trastuzumab were older and of more advanced disease stage compared with those receiving chemotherapy (58.5 vs 51 years, 39.8% vs 28.8% advanced disease). In univariate analysis, subcutaneous trastuzumab was associated with less nausea and vomiting (P = .002) but worse cognitive function (P = .013) and dyspnea (P = .042). Patients who have received >8 cycles of subcutaneous trastuzumab reported less diarrhea (P = .049) and systemic therapy side effects (P = .015). Multivariate analysis showed that patients without comorbidity receiving subcutaneous trastuzumab had less treatment side effects, less upset by hair loss, and higher emotional functioning. Of note, mastectomy and subcutaneous trastuzumab were associated with improved role functioning (P = .021). In metastatic disease, no negative impact of subcutaneous trastuzumab on HRQoL was found.Conclusions:The administration of subcutaneous trastuzumab improved certain symptoms and did not adversely affect most of the assessed functional scales. Particularly, in the metastatic setting, subcutaneous trastuzumab had no negative impact on HRQoL.

POLARIS: a Prospective, Multicenter, Noninterventional Study Assessing Palbociclib in Hormone Receptor-Positive Advanced Breast Cancer

“…POLARIS is preceded by other breast cancer registries collecting data from real-world settings, including ATHENA [34], RegistHER [35][36][37][38], SystHERS and MedSIR (ClinicalTrials.gov: NCT03819010). Additionally, a standalone study collecting HRQoL data from patients with HER2+ early or metastatic breast cancer treated with trastuzumab or chemotherapy in routine practice has been published recently [39]. These registries and observational studies comport with the current growing interest in and use of real-world data sources in breast cancer research, particularly those linking electronic health records on treatment and outcomes to prospective cancer registries, to address clinically relevant questions that may not be answered in clinical trials [40].…”

Safety profile of subcutaneous trastuzumab in patients with HER2-positive early breast cancer: The French HERmione non-interventional prospective study

“…Nevertheless, these results, taking into account the good functional level of patients at baseline, are consistent with expectation: QoL analyses showed no deterioration of global health status. Recent reports also showed that patients without comorbidity receiving subcutaneous trastuzumab had less treatment side effects, less upset by hair loss, and higher emotional functioning [15].…”

Quality of care in the course of subcutaneous versus intravenous trastuzumab administration in patients with breast cancer: an integrated time–motion study with mixed-methods research

“…Those authors used different HRQoL measures (eg, the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) and compared patients receiving subcutaneous trastuzumab with control patients not receiving subcutaneous trastuzumab. 30 The patients' concern over feeling uncomfortable during the trastuzumab administration and focus on trastuzumab injection alone were similar for both the subcutaneous and intravenous forms; this finding is consistent with the systematic review by Dent et al 15 While nurses seemed to have more concerns over reduced interactions with patients due to their painful experiences or administering injections in private body sites in the subcutaneous form, both physicians and pharmacists reported concerns related to their professional tasks while preparing the dosage form (eg, prescribing, dispensing, preparation) in administration processes. From the physicians' perspective, their major concern was the patient preferences, in terms of safety, effectiveness, cost and convenience 15 rather than efficiency, when deciding the dosage form.…”